NCT05672966尚未招募1 期
A Phase I, First-in-human, Randomized, Observer-blinded, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV601 in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety in terms of dose-limiting toxicity (DLT)
研究概览
简要总结
This is a Phase I, first-in-human, randomized, observer-blinded, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and immunogenicity of BV601 (a HPV Vaccine) in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18 and 35 years (inclusive) at the time of Screening Visit.
- •In good general health, with no significant medical history, and have no clinically significant abnormalities on vital signs, physical examination, laboratory tests, and ECG at Screening Visit and before the first vaccination of IP at the discretion of the Investigator(s) or designee.
- •Body Mass Index (BMI) of ≥ 18.0 and ≤ 32.0 (BMI will be calculated by weight in kilograms [kg]/square of height in meters [m2]) and weigh at least 50 kg at Screening Visit.
- •Able and willing to comply with all study requirements and study procedures.
- •Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
- •Male and female of childbearing age should agree to take effective contraception measures
排除标准
- •Physical or psychological medical histories (within 3 months prior to Screening Visit) or ongoing conditions of any clinically significant hepatic (eg, active liver disease, hepatic impairment), renal/genitourinary (eg, renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological, hematological disease, and/or any other medical conditions which, at the discretion of the Investigator(s), may jeopardize the safety of the participants and/or effect the results of the study.
- •Histories or on-going conditions of immune function impaired, congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases.
- •Histories or on-going conditions of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago.
- •History of abnormal cervical biopsy results (showing cervical intraepithelial neoplasia or worse) or cervical disease (ie, surgical treatment for cervical lesions) within 5 years prior to Screening Visit.
- •History of a positive test for HPV infection.
- •Histories of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
- •Loss of spleen or functional spleen, and/or removal of spleen caused by any situation
- •Body temperature before vaccination ≥ 38℃ for ear or temporal artery temperature or ≥ 37.2 ℃ for armpit temperature before vaccination.
- •Systolic blood pressure ≥ 140 mmHg and/or a diastolic blood pressure ≥ 90 mmHg before vaccination.
- •Receipt of systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- •Receipt of immunoglobulins and/or any blood products within the 3 months prior to the first vaccination or planned administration during the study period.
- •Receipt of any HPV vaccination within 3 months prior to the first vaccination. Receipt of any vaccination other than HPV vaccination within 30 days prior to first vaccination. Plan to receive any vaccination within 7 days prior to the secondary or third IP vaccination. Plan to receive any vaccination within 30 days after the first, secondary, or third IP vaccination.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first vaccination of IP.
- •Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD), over the counter (OTC) medication, or herbal remedies 2 weeks prior to dosing and during course of study, unless the medication will not affect the safety and efficacy evaluations in the study at the discretion of the Investigator(s).
- •Regular alcohol consumption defined as > 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- •Positive toxicology panel (urine test including qualitative identification of barbiturates, THC, amphetamines, benzodiazepines, opiates, and cocaine).
- •Positive results of hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), HIV antibody, HPV, SARS-CoV-2, and pregnancy test.
- •Pregnancy or breast feeding or plan to get pregnant or breastfeed during the study.
- •Anything that the Investigator(s) considers that may jeopardise the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
研究组 & 干预措施
1-BV601DP(Low dose HPV vaccine with adjuvant)
Experimental
Subjects received low dose of BV601DP
干预措施: Human papillomavirus (HPV) Vaccine (Biological)
1-BV601DPP(Low dose HPV vaccine without adjuvant)
Experimental
Subjects received low dose of BV601DPP
干预措施: Human papillomavirus (HPV) Vaccine (Biological)
1-Placebo
Placebo Comparator
Subjects received placebo
干预措施: Placebo (Biological)
2-BV601DP(High dose HPV vaccine with adjuvant)
Experimental
Subjects received high dose of BV601DP
干预措施: Human papillomavirus (HPV) Vaccine (Biological)
2-BV601DPP(High dose HPV vaccine without adjuvant)
Experimental
Subjects received high dose of BV601DPP
干预措施: Human papillomavirus (HPV) Vaccine (Biological)
2-Placebo
Placebo Comparator
Subjects received placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Safety in terms of dose-limiting toxicity (DLT)
时间窗: within 30 days after the first vaccination
Percentage of participants with dose-limiting toxicity
Safety in terms of all solicited and unsolicited AEs
时间窗: 365 days after the first vaccination
Frequency and severity of solicited and unsolicited AEs
Safety in terms of unsolicited AEs
时间窗: 365 days after the first vaccination
Percentage of participants with unsolicited AEs
Safety in terms of solicited adverse events
时间窗: within 7 days after each vaccination
Occurrence of solicited AEs of each subject
Safety in terms of solicited systemic AEs
时间窗: within 7 days after the first vaccination
Occurrence of solicited systemic AEs of each subject
次要结局
- Immunogencity in terms of Seroconversion rate(Days 1, 31, 61, 91, 121, 181, 211, and 365)
- Immunogencity in terms of GMT by ELISA(Days 1, 31, 61, 91, 121, 181, 211, and 365)
- Immunogencity in terms of Nab(Days 1, 31, 61, 91, 121, 181, 211, and 365)
研究者
研究点 (1)
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